Does Treating Obstructive Sleep Apnea in Obese Canadian Youth Improve Blood Sugar Control?

NCT01116375 | Completed

• 1 other identifier: 1234
• Study Type: observational
• Target: 27
• Locations: 1 country
• Sites: 4

Brief Summary

To determine whether, in obese children with moderate-severe Obstructive Sleep Apnea who are prescribed Positive Airway Pressure(PAP) therapy, increased hours of PAP usage per night over a one-year period is associated with a greater improvement in HOMA-IR

Conditions

Obesity; Obstructive Sleep Apnea

Keywords

Obesity; OSA; PAP therapy

Outcome Measures

Primary Outcomes (1)

• HOMA-IR

  Euglycemichyperinsulinemic clamp technique is the gold standard measurement technique for insulin resistance however, invasive and rarely used in clinical practice. A surrogate is the homeostasis model assessment (HOMA) formula for insulin resistance (HOMA-IR) Thus, lower HOMA values indicate higher insulin sensitivity. The estimate obtained with HOMA correlates well with measures of insulin resistance obtained from obese and non-obese children and adolescents with the clamp technique

  1 year after start of PAP therapy

Secondary Outcomes (6)

• Systemic Hypertension

  1 year after start of treatment with PAP

• Heart rate and heart rate variability

  1 year after the start of PAP therapy

• hsCRP

  1 year after start of PAP therapy

• Conners' Parent and Teacher Rating Scales

  1 Year fter the start fo PAP therapy

• Child Behavior Checklist

  1 year after start of PAPA therapy

Study Arms (1)

Obese children with OSA

To determine whether, in obese children with moderate-severe OSA who are prescribed PAP therapy, increased hours of PAP usage per night over a one-year period is associated with a greater improvement in HOMA-IR

Eligibility Criteria

• Age: 8 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Obese children (body mass index (BMI) ≥ 95th %ile for age and sex) 8-17 years old with moderate-severe OSA will be recruited for this study from four pediatric tertiary care centres across Canada. As per current standard of care, those children with moderate-severe OSA, defined as ≥ 10 obstructive events per hour on polysomnography, will be prescribed PAP treatment.

You may qualify if:

• Age 8 to 16 years
• Obesity, defined as body mass index greater than or equal to the 95th percentile for gender and age (2000 CDC Growth Charts for US)
• Moderate to severe OSA diagnosed on polysomnography, for which PAP therapy (continuous positive airway pressure or bi-level positive airway pressure) is prescribed by a physician. Overnight laboratory polysomnography, the gold standard for assessment of OSA115 and titration of PAP, will be performed and scored by a certified sleep technician, according to the American Academy of Sleep Medicine recommendations. Moderate to severe OSA will be defined as an obstructive apneahypopnea index (OAHI) of greater than or equal to 10 apneas or hypopneas per hour. Although no strict guidelines for defining severity of OSA in children exist, the definition for this study was derived by a consensus of pan-Canadian pediatric sleep medicine experts.
• Parents/guardians and children must also be fluent in English or French.

You may not qualify if:

• craniofacial anomalies other than tonsillar and adenoid enlargement118, 119
• central nervous system lesions
• neuromuscular, neurological, or genetic syndromes
• congenital heart disease and/or diagnosed ventricular dysfunction
• chronic respiratory disease with the exception of asthma
• use of oral or intravenous corticosteroids within the past 3 months (as this would affect the primary outcome).
• prior exposure to PAP therapy

Sponsors & Collaborators

• Katz, Sherri Lynne, M.D.: lead
• Canadian Institutes of Health Research (CIHR): collaborator

Study Sites (4)

Alberta Children's Hospital

Calgary, Alberta, Canada

Location

Stollery Children's Hospital

Edmonton, Alberta, Canada

Location

Childrens Hospital of Eastern Ontario

Ottawa, Ontario, Canada

Location

Montreal Childrens Hospital

Montreal, Quebec, Canada

Location

MeSH Terms

Conditions

Obesity; Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Officials

• Evelyn Constantin, MD

  Montreal Children's Hospital of the MUHC

  PRINCIPAL INVESTIGATOR

• Sherri L Katz, md

  Childrens Hospital of Eatern Ontario

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDIV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Katz, Sherri Lynne, M.D.

Study Record Dates

• First Submitted: April 30, 2010
• First Posted: May 5, 2010
• Study Start: June 1, 2010
• Primary Completion: July 1, 2014
• Study Completion: September 1, 2014
• Last Updated: March 9, 2018

Record last verified: 2018-03

Locations

CA (4)